Positive initial phase 2a study data with ANAVEX 2-73 showing early evidence of improving cognition in patients with Alzheimer's disease

Anavex Life Sciences Corp. has announced initial positive cognitive data for ANAVEX 2-73, the Company's lead investigational oral treatment for Alzheimer's targeting sigma-1 and muscarinic receptors, which is believed to reduce protein misfolding including reduction of beta amyloid, tau and inflammation. Cognitive EEG/ERP P300 data, a real-time physiological measure of cognitive processes with demonstrated sensitivity to Alzheimer's disease, is being presented today for the first 12 of 32 mild-to-moderate Alzheimer's patients in the ongoing ANAVEX 2-73 Phase 2a clinical trial at AAIC 2015 in Washington, DC.

ANAVEX 2-73 showed in 83 percent (10/12) of patients positive cognitive effects during PART A of the study, which consists of a 36-day on-off-on not-yet-optimized dosing regimen to assess bioavailability. At day 36, the amplitude of the cognitive EEG/ERP biomarker P300 increased 38 percent from baseline. Published data suggests that a 38 percent increase is approximately 4 times higher than donepezil (Aricept®), the current standard of care, in the same timeframe.

Preliminary measured Mini Mental State Examination (MMSE) and Cogstate scale changes are consistent with the observed trend of the cognitive EEG/ERP effect. The safety profile of ANAVEX 2-73 during Phase 2a appears consistent with the Phase 1 data; additional clinical data of the trial will be presented at future medical meetings.

"This is the first time the investigational drug ANAVEX 2-73 has been administered to Alzheimer's patients. In addition to the positive EEG/ERP P300 biomarker signal, the feedback we've had so far is that patients and care providers have noticed both cognitive and functional improvement, increased alertness, improvement in activities of daily living, greater organization and a requirement for less prompting," said study's principal investigator Dr. Stephen Macfarlane, FRANZCP, Associate Professor and Director of Aged Psychiatry at The Alfred Hospital. "Subsequent to the positive initial feedback, we are applying to expand the extension period from 26 weeks to 52 weeks at the request of the participants."

"We are cautiously optimistic given the encouraging feedback and the preliminary cognitive data. We look forward to the full ANAVEX 2-73 Phase 2a trial results," said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "As of today, we have enrolled two-thirds of the patients. We expect the trial to be fully enrolled and to have PART A completed by the end of the year."

The poster entitled "New Exploratory Alzheimer's Drug ANAVEX 2-73 Changes in Electrophysiological Markers in Alzheimer's Disease - First Patient Data from an ongoing Phase 2a Study in mild-to-moderate Alzheimer's Patients" was co-authored by Steve Macfarlane, Marco Cecchi, Dennis Moore, Anastasios Zografidis and Christopher Missling and is available on the publications page of the Anavex website.

About the ANAVEX 2-73 Phase 2a Study

The ongoing, multicenter Phase 2a adaptive trial of ANAVEX 2-73 in both male and female mild-to-moderate Alzheimer's patients seeks to enroll 32 patients. It started in January 2015 and the first 12 patients, most who are also taking donepezil, have completed PART A of the two-part trial. Lasting up to 36 days for each patient, PART A is a simple randomized, open-label, two-period trial with an on-off-on not-yet-optimized dosing regimen to assess bioavailability, and cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration. Event-related potentials (EEG/ERP) are used to assess cognitive effects and optimize dosing of ANAVEX 2-73. PART B is an open-label extension for an additional 26 weeks, with daily oral dosing so as to establish a longer drug effect.

The primary endpoint of the Phase 2a trial is evaluation of the maximum tolerated dose of ANAVEX 2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints are dose response, bioavailability, exploratory cognitive effects using electroencephalographic (EEG) activity, including event-related potentials (EEG/ERP), Mini Mental State Examination (MMSE), Cogstate and evaluation of ADSC-ADL and add-on therapy to donepezil, the current standard of care, which represents ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®).

Additional information regarding the trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.